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New treatment option for Mild Cognitive Impairment
Official title Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)
ClinicalTrials.gov ID: NCT04601038
What this study is testing
What is CORT108297?
CORT108297 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mild cognitive impairment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- CORT-X will examine if mitigation of stress-mediated pathogenesis of Alzheimer's disease (AD) is a feasible target for intervention in individuals at risk for this disease. This single-site (Baltimore, Maryland) phase II clinical trial is a 2-week, randomized, placebo-controlled crossover study of the effects of the selective glucocorticoid receptor antagonist, CORT108297, on cognitive test performance in 26 individuals with mild cognitive impairment (MCI) due to AD and in 26 cognitively normal individuals with an increased risk for AD due to family history, genetics, and/or subjective memory complaints.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older. Healthy volunteers may be eligible.
You may be able to join if
- Individuals must meet criteria for mild cognitive impairment due to Alzheimer's disease according to National Institute on Aging (NIA)/Alzheimer's...
- Known to have at least 1 apolipoprotein E (APOE) ε4 allele;
- Subjective cognitive concerns with a T score \< 40 on the Multifactorial Memory Questionnaire Satisfaction Scale;
- A first-degree relative with dementia. for all people:
- At least 55 years of age;
You likely can't join if
- for all people:
- Participation in a therapeutic clinical trial at any time during the study;
- Abnormal corrected QT interval using Bazett's formula (QTcB; defined as \> 450 ms for men and \> 470 ms for women) as determined on ECG;
- Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia...
- Bipolar disorder within the past 1 year;
- History of alcohol or drug dependence;
See the full eligibility criteria
- Individuals must meet criteria for mild cognitive impairment due to Alzheimer's disease according to National Institute on Aging (NIA)/Alzheimer's Association recommendations OR be cognitively normal based on clinical...
- Known to have at least 1 apolipoprotein E (APOE) ε4 allele;
- Subjective cognitive concerns with a T score \< 40 on the Multifactorial Memory Questionnaire Satisfaction Scale;
- A first-degree relative with dementia. for all people:
- At least 55 years of age;
- Body mass index \>17 and \<30;
- Post-menopausal (if female)
- Non-smoker;
- Availability of a study partner who has frequent contact with the subject (10+ hours/week in person and by telephone), and is able to provide an independent evaluation of functioning;
- Fluent English speaker;
- Good general health with no disease expected to interfere with the study;
- Willing and able to participate for the duration of the study.
- for all people:
- Participation in a therapeutic clinical trial at any time during the study;
- Abnormal corrected QT interval using Bazett's formula (QTcB; defined as \> 450 ms for men and \> 470 ms for women) as determined on ECG;
- Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive...
- Bipolar disorder within the past 1 year;
- History of alcohol or drug dependence;
- Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol;
- General surgery within the last 3 months;
- Sensory impairment (poor vision or hearing) significant enough to interfere with ability to provide valid cognitive test data;
- Treatment within the last six months with neuroleptics, sedative hypnotics, or glucocorticoids;
- Treatment within the last six months with medications metabolized by the CYP2C9 or CYP2C19 enzymes, most notably clopidogrel and proton pump inhibitors;
- Concurrent use of a CYP3A inhibitor, including grapefruit juice, and St. John's Wort;
- Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the PI.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.